Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)

Dementia (Diagnosis) Clinical Trial

Official title:

Cognition and NeuroImaging in neuroDegenerative Disorders (CogNID)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03861884
• Other study ID #: 18NS001
• Status: Recruiting
• Start date: December 12, 2018
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Nottingham University Hospitals NHS Trust
• Contact: Akram Dr Hosseini
• Phone: 0115 924 9924
• Email: Akram.Hosseini[@]nuh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective study aims:

1. to compare cognitive performance in different clinical groups of participants with mild cognitive impairment (MCI) or mild dementia [Alzheimer's Disease (AD), Vascular Cognitive Impairment (VCI) and Fronto-temporal Dementia (FTD)] to determine whether scores reveal differential profiles between the groups,

2. to demonstrate differences in imaging markers between different dementia syndromes and healthy volunteers using ultra high-field MRI at 7T.

Description:

The imaging arm of the study include:

1. to demonstrate differences in brain iron levels between different dementia syndromes and healthy volunteers using ultra high-field MRI, quantitative susceptibility mapping (QSM) at 7T.

2. to demonstrate variations in the resting oxygen usage as an important biomarker to discriminate between different dementia syndromes.

3. to demonstrate cerebral blood flow changes in the brain, particularly in the hippocampus region, and its correlation with different dementia syndromes using Arterial Spin Labelling MRI technique.

4. to demonstrate increased blood brain barrier leakage in the brain, particularly in the hippocampus region, and its correlation with Alzheimer's Disease (AD) and Vascular Cognitive Impairment (VCI) using a new dynamic contrast-enhanced MRI (DCE-MRI) technique.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ability to give informed consent.

2. Either pathological, genetic or imaging biomarker evidence to suggest Fronto-temporal Lobar Degeneration, Alzheimer's Disease or Vascular Cognitive Impairment, or defined clinical diagnoses.

Exclusion Criteria:

1. Lack of mental capacity to consent to study involvement.

2. Not speaking English before age 5 years.

3. Learning disability.

4. MRI contraindications

Related Conditions & MeSH terms

• Dementia
• Dementia (Diagnosis)
• Neurodegenerative Diseases

Intervention

Diagnostic Test:
• Cognitive assessments
Cognitive assessment and MRI at 3T and/or 7T

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	East Midland
United Kingdom	Nottinghamshire Healthcare NHS Foundation Trust	Nottingham	Easat Midland

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive scales on Birmingham Cognitive Screen (BCoS) Scores	cognitive sub scores in relation to clinical phenotype	Through study completion (an average of one year)
Secondary	Structural imaging changes on MRI at 3T	Structural volume loss	Through study completion (an average of one year)
Secondary	Susceptibility weighted mapping at 7T	Quantitative Susceptibility Mapping	Through study completion (an average of one year)